Evidence map›Paper›PMID 30463622›Full record

ArticleTrials2018

High-intensity versus low-intensity noninvasive positive pressure ventilation in patients with acute exacerbation of chronic obstructive pulmonary disease (HAPPEN): study protocol for a multicenter randomized controlled trial.

Zujin Luo, Chao Wu, Qi Li, Jian Zhu, Baosen Pang, Yan Shi, Yingmin Ma, Zhixin Cao, HAPPEN collaboration group

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02985918 (Effect of High-Intensity vs Low-Intensity Noninvasive Positive Pressure Ventilation on the Need for Endotracheal Intubation in Patients With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease The HAPPEN Randomized Clinical Trial), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 40% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02985918 naterminatednot on this mapstarted 2019, after this paper: background citation

Effect of High-Intensity vs Low-Intensity Noninvasive Positive Pressure Ventilation on the Need for Endotracheal Intubation in Patients With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease The HAPPEN Randomized Clinical Trial

TypeinterventionalSponsorBeijing Chao Yang HospitalRan2019 to 2022Enrolled300ConditionsAcute Exacerbation of Chronic Obstructive Pulmonary DiseaseArmsHigh-intensity NPPV, Low-intensity NPPV
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. Non-Invasive Ventilatory Support In the Elderly.Current geriatrics reports · 2019
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 1 country.

Zujin LuoDepartment of Respiratory and Critical Care Medicine, Beijing Engineering Research Center of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine, Beijing Chao-Yang Hospital, Capital Medical University, 5 Jingyuan Road, Shijingshan District, Beijing, 100043, China.
Chao WuDepartment of Respiratory and Critical Care Medicine, People's Hospital of Xinjiang Uygur Autonomous Region, No. 91 Tianchi Road, Tianshan District, Urumqi, 830001, China.
Qi LiDepartment of Respiratory and Critical Care Medicine, Army Institute of Respiratory Disease, Chongqing Xin-Qiao Hospital, Army Military Medical University, 183 Xinqiao Main Street, Shapingba District, Chongqing, 400073, China.
Jian ZhuDepartment of Respiratory and Critical Care Medicine, Beijing Engineering Research Center of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine, Beijing Chao-Yang Hospital, Capital Medical University, 5 Jingyuan Road, Shijingshan District, Beijing, 100043, China.
Baosen PangDepartment of Respiratory and Critical Care Medicine, Beijing Engineering Research Center of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine, Beijing Chao-Yang Hospital, Capital Medical University, 5 Jingyuan Road, Shijingshan District, Beijing, 100043, China.
Yan ShiSchool of Automation Science and Electrical Engineering, Beihang University, No. 37 Xueyuan Road, Haidian District, Beijing, 100191, China. shiyan@buaa.edu.cn.
Yingmin MaDepartment of Respiratory and Critical Care Medicine, Beijing Engineering Research Center of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine, Beijing Chao-Yang Hospital, Capital Medical University, 5 Jingyuan Road, Shijingshan District, Beijing, 100043, China. ma.yingmin@163.com.
Zhixin CaoDepartment of Respiratory and Critical Care Medicine, Beijing Engineering Research Center of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine, Beijing Chao-Yang Hospital, Capital Medical University, 5 Jingyuan Road, Shijingshan District, Beijing, 100043, China. caozhixinicu@126.com.
HAPPEN collaboration group
Capital Medical University · CNBeijing Chao-Yang Hospital · CNBeihang University · CNPeople's Hospital of Xinjiang Uygur Autonomous Region · CNXinqiao Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDespite the positive outcomes of the use of noninvasive positive pressure ventilation (NPPV) in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD), NPPV fails in approximately 15% of patients with AECOPD, possibly because the inspiratory pressure delivered by conventional low-intensity NPPV is insufficient to improve ventilatory status for these patients. High-intensity NPPV, a novel form that delivers high inspiratory pressure, is believed to more efficiently augment alveolar ventilation than low-intensity NPPV, and it has been shown to improve ventilatory status more than low-intensity NPPV in stable AECOPD patients. Whether the application of high-intensity NPPV has therapeutic advantages over low-intensity NPPV in patients with AECOPD remains to be determined. The high-intensity versus low-intensity NPPV in patients with AECOPD (HAPPEN) study will examine whether high-intensity NPPV is more effective for correcting hypercapnia than low-intensity NPPV, hence reducing the need for intubation and improving survival. METHODS/

designThe HAPPEN study is a multicenter, two-arm, single-blind, prospective, randomized controlled trial. In total, 600 AECOPD patients with low to moderate hypercapnic respiratory failure will be included and randomized to receive high-intensity or low-intensity NPPV, with randomization stratified by study center. The primary endpoint is NPPV failure rate, defined as the need for endotracheal intubation and invasive ventilation. Secondary endpoints include the decrement of arterial carbon dioxide tension from baseline to 2 h after randomization, in-hospital and 28-day mortality, and 90-day survival. Patients will be followed up for 90 days after randomization. DISCUSSION: The HAPPEN study will be the first randomized controlled study to investigate whether high-intensity NPPV better corrects hypercapnia and reduces the need for intubation and mortality in AECOPD patients than low-intensity NPPV. The results will help critical care physicians decide the intensity of NPPV delivery to patients with AECOPD.

trial registrationClinicalTrials.gov, NCT02985918 . Registered on 7 December 2016.

Indexed as

ChinaDisease ProgressionHospital MortalityHumansHypercapniaIntubation, IntratrachealLungMulticenter Studies as TopicNoninvasive VentilationPositive-Pressure RespirationProspective StudiesPulmonary Disease, Chronic ObstructiveRandomized Controlled Trials as TopicSingle-Blind MethodTime FactorsTreatment OutcomeChronic obstructive pulmonary diseaseEndotracheal intubationExacerbationHigh-intensityHypercapniaLow-intensityMortalityNoninvasive positive pressure ventilation

Identifiers

PMID30463622
PMCPMC6249746
OpenAlexW2901751398

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.